A New Nasopharyngeal pH Probe for Diagnosis of Laryngopharyngeal Reflux

NCT01308502 | Withdrawn Phase 4

• 1 other identifier: 09-007341
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the utility of a minimally invasive nasopharyngeal pH probe for the diagnosis of laryngopharyngeal reflux (LPR) in children with airway compromise; to determine whether it is comparable to the gold standard esophageal pH probe in identifying LPR in this population; and to correlate results of pH testing with validated questionnaires. Our hypothesis is that a nasopharyngeal pH probe is equivalent to an esophageal probe in identifying laryngopharyngeal reflux.

Conditions

Laryngopharyngeal Reflux

Keywords

laryngopharyngeal reflux; LPR; GERD; gastroesophageal reflux; nasopharyngeal probe

Outcome Measures

Primary Outcomes (1)

• nasopharyngeal pH

  Change in nasopharyngeal pH as measured by the Dx-pH probe

  24 hours

Study Arms (1)

Probe

EXPERIMENTAL

Children with airway obstruction

Device: Dx-pH probe

Interventions

Dx-pH probe DEVICE

Dx-pH probe with 24 hour recording

Also known as: ResTech Dx-pH probe

Probe

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• History of airway compromise
• Undergoing microlaryngoscopy, bronchoscopy, esophagoscopy, and esophageal pH probe placement at CHOP

You may not qualify if:

• Patients not undergoing esophageal pH probe placement
• Neonates under 1 month of age
• Adults over 18 years of age or older.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Laryngopharyngeal Reflux; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Laryngeal Diseases; Respiratory Tract Diseases

Study Officials

• Karen Zur

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director, The Center for Pediatric Airway Disorders, Director Pediatric Voice Program

Study Record Dates

• First Submitted: March 2, 2011
• First Posted: March 4, 2011
• Study Start: January 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: March 30, 2012

Record last verified: 2012-03

Locations

US (1)